This is a single center, prospective cross-sectional study of women who have completed therapy for primary breast cancer within 5 years of diagnosis and are at increased risk for relapse.
Patients will undergo screening bone marrow aspirate to test for presence of disseminated tumor cells (DTCs) Patients who harbor DTCs will be offered the opportunity for enrollment into a clinical trial of therapy targeting DTCs to prevent recurrence (separate protocols).
Histologically-confirmed primary invasive breast cancer within 5 years of study entry
Pathologically-confirmed invasive breast cancer in axillary lymph nodes, regardless of receptors
Primary tumor with triple negative subtype: estrogen receptor (ER) < 10%, progesterone receptor (PR) < 10% and negative Her2-overexpression by ASCO-CAP guidelines
Primary tumor that is ER+/Her2 negative/Lymph node negative with a Breast Cancer Recurrence Score of ≥ 25 per the Genomic Health Oncotype DX breast cancer test and/or HighRisk MammaPrint
Concurrent enrollment on another investigational therapy
Patients receiving chronic, high dose systemic treatment with corticosteroids defined as: chronic use of cortisone >50mg; hydrocortisone >40mg, prednisone >10mg, methylprednisone >8mg or dexamethasone >1.5mg; or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
EKG demonstrating QTC > 480 ms
History or evidence of increased cardiovascular risk including any of the following: (i) current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation, (ii) History of acute coronary syndromes (including myocardial infarction and unstable angina, coronary angioplasty, or stenting within 6 months prior to enrollment, (iii) Current >/= Class II congestive heart failure as defined by New York Heart Association